Research On The Preparation And Quality Standard Of Chaihuang Soft Capsule

Chaihuang soft capsule was recorded in "Drug Standard (20th edition)"of the Chinese medicine preparations compiled by the Ministry of Health, People's Republic of China, which is composed of extractions from Bupleurum chinense and Scutellaria baicalensis.Chaihuang soft capsule has the effects of curing heat-infammatory. It was used in clinic for the treatment of respiratory infection and cold. The clinical practice proved its favorable curative effect and its widespread usage. Due to the existing defective extraction technique and the relatively low quality control standard, the Chaihuang soft capsule are easy to disintegrate, dissolve, stratify, and leak during storage. In this thesis, the new soft capsule pouch skin fabric's various components, the composition and the matrix allocated proportion were investigated in order to improve the solubility and stability of Chaihuang soft capsule. Moreover, its quality control was also studied with aim to improve the stability, safety and effectiveness of the drug.The HPLC method was used to determine the contents of saikosaponin a in Chaihuang soft capsule and the yield of dry extraction. The orthogonal testing method was utilized for optimizing the process of water extraction and alcohol precipitation of Bupleurum chinens. Such optimized process is to soak these meterials in water with a volume that is 8 times more than them for 2 hours, then to decoct them for two times.50% ethanol was favorable. Experimental results showed that this method is applicable for large-scale manufacturing.Proportioning experiments of supplementary materials are conductedin order to determine the prescription of Chaihuang soft capsule. The soft capsules are manufactured by encapsulating the suspension that is made of the extracted and auxiliary materials. Each capsule contains a total mass of baicalin not less than 70.0 mg. In order to determine the optimal composition for capsule shells, orthogonal tests are carried out to explore the effects of the ratio of gelatin to glycerin, the ratio of water to gelatin, and the melt temperature. The observed optimal composition is:gelatin:glycerin:water= 2:1:2, with a melt temperature of 70℃TLC technique is utilized to identify qualitatively the Bupleurum chinense. Moreover, the HPLC technique is used to measure the baicalin, and the linear equation of baicalin is proposed by using the external standard method: baicalin RSD 1.3%, average recovery 98.9%. It is shown that this method is simple, reproducible, and can be used as a quality control route for Xiangshayangwei soft capsule.Stability is well exhibited by performing the 6-months preliminary stability tests in normal temperature on three batches of samples.In conclusion, in this study the preparation technique of Chaihuang soft capsule has been optimized and an effective quality control method has been proposed as well. By doing so, the stability of the product has been shown to be improved, which provides a theoretical and experimental guide for large-scale manufacturing.